SmokingNCT07323511
Abuse Liability for Eight Electronic Nicotine Products
A study testing Product A, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company.
Trial summary
This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics [PD]), and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of Electronic Nicotine… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, Tobacco Use
- What is being tested?
- Product A, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive (≥200 ng/ml) urine cotinine test at Screening.
- Smokes only combustible filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.
- Agrees to smoke same UB cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the participant.
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- Participants must meet one (a or b) of the following tobacco use conditions:
- Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (more than 30 days prior to Screening), or clinical study participation (more than 30 days prior to Screening) will be allowed at the discretion of the Principal Investigator (PI).
- Dual user of cigarettes and ENDS who self-reports:
- Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the PI and ii. Using a nicotine-containing ENDS (cartridge or a tank system). NOTE: Cigarette smokers or ENDS users who also use other tobacco- or nicotine-containing products (e.g., smokeless tobacco, and modern oral nicotine products) on no more than one day per week will not be excluded from study participation.
- Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes."
- Willing to use only UB cigarette, ENDS IPs, and nicotine gum during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each test session.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
- Males must use an acceptable method of birth control from Day 1 "check-in" until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children.
- Agrees to in-clinic confinement of 10 days and 9 nights.
Who cannot join
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
- Weight of ≤ 110 pounds at Screening.
- Hemoglobin level is < 12.5 g/dL for females or <13.0 g/dL for males at Screening.
- Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion.
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- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Must not be a current regular user (i.e., > 5 times per month) of any tobacco products other than cigarettes or ENDS within the last 6 months prior to screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Wegovy®, Mounjaro®, and Ozempic®), or lobelia extract within ≤ 30 days prior to the signing of informed consent.
- History or presence of bleeding or clotting disorders.
- Use of daily aspirin (≥ 325 mg) or other daily anticoagulants.
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
- NOTE: Participants will be advised against scheduling a whole blood donation for at least 7 days following study completion.
- Plasma donation within ≤ 7 days prior to the signing of informed consent and between Screening and check-in Day 1.
- NOTE: Participants will be advised against scheduling a plasma donation for at least 7 days following study completion.
- Participation in another clinical trial within ≤ 30 days prior to the signing of informed consent. The 30-day window for each participant will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
- Females who have a positive pregnancy test at Screening or check-in on Day 1, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within ≤ 30 days prior to the signing of the ICF.
- Has a significant history of alcoholism or drug abuse within 24 months prior to Screening, as determined by the PI, or has a positive alcohol test at Screening or check-in on Day 1.
- Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Individuals or their family members that have ongoing litigation with tobacco company(ies).
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Randomized, 8-way Crossover Study to Assess Elements of Abuse Liability of Electronic Nicotine Delivery System Products in Adult Smokers
This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics [PD]), and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
Read the detailed description
Adult smokers of filtered menthol and/or non-menthol cigarettes and smokers who also use ENDS will be recruited into this study to evaluate elements of ENDS IP AL, in comparison to participant's usual brand (UB) cigarette and nicotine polacrilex gum.
Potential participants will undergo a pre-screening interview followed by a Screening Visit within 28 days prior to enrollment, randomization, and study confinement to assess eligibility.
Eligible participants will be scheduled for a check-in and randomization visit. At this visit, eligibility will be reconfirmed prior to randomization to a product use sequence, based on a Williams design. Participants will then enter a 10-day, 9-night confinement period.
On study Day 1, participants will enter a product familiarization period during which they will be required to use three ENDS IP (Products B,, Product D Product F, and nicotine gum (Product N) at least once. Use of each product during familiarization period will be approximately 5 minutes for each ENDS IP and approximately 30 minutes for a single piece of nicotine gum. After completing this familiarization, they will be permitted to smoke their UB cigarettes ad libitum. Participants who also use other tobacco and/or nicotine-containing products such as ENDS, smokeless tobacco or modern oral nicotine products in addition to their UB cigarettes will not have access to those products during the study.
Following the product familiarization period, participants will enter a product acclimation period (beginning on Day 2 and each day prior to a test session) during which they will use their randomized IP (excluding their UB cigarette) assigned for use in the next day's test session at least four times, for approximately 5 minutes per use for ENDS IPs and approximately 30 minutes for a single piece of nicotine gum use. After completing this requirement, participants will be permitted to smoke their UB cigarettes ad libitum. Pharmacy logs will be used to capture information on product usage during the product familiarization and acclimation periods.
At the end of the product acclimation period and ad libitum use of the participant's UB cigarette, participants will abstain from use of all tobacco- and nicotine-containing products for a minimum of 12 hours prior to each test session occurring on the following day. In addition, participants will be required to abstain from any caffeine-containing products for 4 hours prior to the start of each test session through the end of the test session.
Starting on Day 3 and continuing through Day 10, each participant will participate in eight consecutive daily test sessions, evaluating one IP per session.
Over the course of the study, each participant will evaluate a total of eight IPs:
six ENDS IPs, a high-AL comparator (the participant's UB cigarette), and a low- AL comparator (a commercially available nicotine replacement therapy [NRT] nicotine gum).
During each test session, blood samples will be collected for plasma nicotine PK assessments. Additionally, subjective effects questionnaire responses and physiological measures will be taken before, during, and after each product use.
The active period of each test session will start with assigned IP use initiation and last approximately 4 hours during and following product use. During each test session, participants will be allowed approximately 5 minutes of smoking one UB cigarette; approximately 5 minutes of ENDS IP use; or approximately 30 minutes of nicotine gum use (one piece per package labeling), based on the product use sequence to which participants will be randomized. Participants' use of the ENDS IP will be self-defined during the 5-minute ad libitum IP use session; specific parameters around puff duration, volume, inter puff interval, and quantity will not be prescribed. ENDS IP cartridges will be weighed within 4 hours before and after the test session on Days 3 - 10.
Participant safety will be monitored throughout the study by the Principal Investigator (PI) or qualified designee by adverse events (AEs) assessments, vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. The Medical Monitor will be available for consultation throughout the study and for any necessary follow-up after discharge.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- Product A, Product B, Product C, Product D, Product E
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Product BOther
Also called P2815222
Tobacco Flavor, 5%
Product COther
Also called P2815216
Tobacco Flavor, 1.5%
Product DOther
Also called P29156222
Tobacco Flavor, 5%
Product EOther
Also called P2615222
Tobacco Flavor, 2.4%
Product FOther
Also called P2615217
Tobacco Flavor, 5%
Product GOther
Also called P2915322
Mint Flavor, 5%
Product NOther
Nicorette® White Ice Mint 4 mg nicotine polacrilex gum
| Study group | Role | What they receive |
|---|---|---|
| Product usage order ANBGCFDE | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order BACNDGEF | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order CBDAENFG | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order DCEBFAGN | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order EDFCGBNA | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order FEGDNCAB | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order GFNEADBC | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
| Product usage order NGAFBECD | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G; Other: Product N |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUECPL 3-240
area under the effect curve (AUEC) for PL (VAS score-versus-time)
Measured: 3 minutes to 240 minutes
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milly Kanobe, Study director, Reynolds American
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323511
- Sponsor's protocol ID
- CSD252101
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 8-way Crossover Study to Assess Elements of Abuse Liability of Electronic Nicotine Delivery System Products in Adult Smokers
- ClinicalTrials.gov ID
- NCT07323511
- Acronym / sponsor ID
- CSD252101
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics [PD]), and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
Detailed description
Adult smokers of filtered menthol and/or non-menthol cigarettes and smokers who also use ENDS will be recruited into this study to evaluate elements of ENDS IP AL, in comparison to participant's usual brand (UB) cigarette and nicotine polacrilex gum.
Potential participants will undergo a pre-screening interview followed by a Screening Visit within 28 days prior to enrollment, randomization, and study confinement to assess eligibility.
Eligible participants will be scheduled for a check-in and randomization visit. At this visit, eligibility will be reconfirmed prior to randomization to a product use sequence, based on a Williams design. Participants will then enter a 10-day, 9-night confinement period.
On study Day 1, participants will enter a product familiarization period during which they will be required to use three ENDS IP (Products B,, Product D Product F, and nicotine gum (Product N) at least once. Use of each product during familiarization period will be approximately 5 minutes for each ENDS IP and approximately 30 minutes for a single piece of nicotine gum. After completing this familiarization, they will be permitted to smoke their UB cigarettes ad libitum. Participants who also use other tobacco and/or nicotine-containing products such as ENDS, smokeless tobacco or modern oral nicotine products in addition to their UB cigarettes will not have access to those products during the study.
Following the product familiarization period, participants will enter a product acclimation period (beginning on Day 2 and each day prior to a test session) during which they will use their randomized IP (excluding their UB cigarette) assigned for use in the next day's test session at least four times, for approximately 5 minutes per use for ENDS IPs and approximately 30 minutes for a single piece of nicotine gum use. After completing this requirement, participants will be permitted to smoke their UB cigarettes ad libitum. Pharmacy logs will be used to capture information on product usage during the product familiarization and acclimation periods.
At the end of the product acclimation period and ad libitum use of the participant's UB cigarette, participants will abstain from use of all tobacco- and nicotine-containing products for a minimum of 12 hours prior to each test session occurring on the following day. In addition, participants will be required to abstain from any caffeine-containing products for 4 hours prior to the start of each test session through the end of the test session.
Starting on Day 3 and continuing through Day 10, each participant will participate in eight consecutive daily test sessions, evaluating one IP per session.
Over the course of the study, each participant will evaluate a total of eight IPs:
six ENDS IPs, a high-AL comparator (the participant's UB cigarette), and a low- AL comparator (a commercially available nicotine replacement therapy [NRT] nicotine gum).
During each test session, blood samples will be collected for plasma nicotine PK assessments. Additionally, subjective effects questionnaire responses and physiological measures will be taken before, during, and after each product use.
The active period of each test session will start with assigned IP use initiation and last approximately 4 hours during and following product use. During each test session, participants will be allowed approximately 5 minutes of smoking one UB cigarette; approximately 5 minutes of ENDS IP use; or approximately 30 minutes of nicotine gum use (one piece per package labeling), based on the product use sequence to which participants will be randomized. Participants' use of the ENDS IP will be self-defined during the 5-minute ad libitum IP use session; specific parameters around puff duration, volume, inter puff interval, and quantity will not be prescribed. ENDS IP cartridges will be weighed within 4 hours before and after the test session on Days 3 - 10.
Participant safety will be monitored throughout the study by the Principal Investigator (PI) or qualified designee by adverse events (AEs) assessments, vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. The Medical Monitor will be available for consultation throughout the study and for any necessary follow-up after discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Product usage order ANBGCFDE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order BACNDGEF | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order CBDAENFG | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order DCEBFAGN | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order EDFCGBNA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order FEGDNCAB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order GFNEADBC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
| Product usage order NGAFBECD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product G, Other: Product NSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive (≥200 ng/ml) urine cotinine test at Screening.
- Smokes only combustible filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.
Key exclusion criteria (25 listed)
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
- Weight of ≤ 110 pounds at Screening.
- Hemoglobin level is < 12.5 g/dL for females or <13.0 g/dL for males at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product AUsual Brand (UB) filtered, menthol or non-menthol combustible cigarette | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product BAlso: P2815222Tobacco Flavor, 5% | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product CAlso: P2815216Tobacco Flavor, 1.5% | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product DAlso: P29156222Tobacco Flavor, 5% | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product EAlso: P2615222Tobacco Flavor, 2.4% | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product FAlso: P2615217Tobacco Flavor, 5% | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product GAlso: P2915322Mint Flavor, 5% | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
| Product NNicorette® White Ice Mint 4 mg nicotine polacrilex gum | Other | Product usage order ANBGCFDE, Product usage order BACNDGEF, Product usage order CBDAENFG, Product usage order DCEBFAGN, Product usage order EDFCGBNA, Product usage order FEGDNCAB, Product usage order GFNEADBC, Product usage order NGAFBECD |
Primary outcome
AUECPL 3-240
Time frame: 3 minutes to 240 minutes
area under the effect curve (AUEC) for PL (VAS score-versus-time)
Emax PL
Time frame: 240 minutes
maximum effect (maximum PL VAS score after the start of IP use)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milly Kanobe study director
Reynolds American
Questions about this trial
What is this clinical trial studying?
A study testing Product A, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Smith (3356-741-2396, smithe13@rjrt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUECPL 3-240 (time frame: 3 minutes to 240 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.